BioSpace

Big Pharma Pushes FDA To Decouple Inspections From Drug Approval Applications

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...
Government Executive

FDA clinical inspections are plummeting due to staffing issues

The Food and Drug Administration is inspecting far fewer pharmaceutical companies conducting clinical research as it adjusts to the post-pandemic world and a smaller workforce, which an auditor warned ...

ProPublica’s New Tool Provides Drug Info the FDA Won’t

The first-of-its-kind app to help you find out where your generic drugs come from and see the track records of the factories ...
JD Supra

I Don’t Want Your Photograph: Actually, FDA Might Want to Take Photographs During an Inspection

While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal ...
Agri-Pulse

Shifting FDA food safety inspection to states has big challenges

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...
Arkansas Democrat-Gazette

FDA’s inspections still lag pre-pandemic period

WASHINGTON -- Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the covid-19 pandemic upended factory ...
FoodBusinessNews

GAO report shows FDA falling short on food inspections

WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the Food Safety: FDA Should Strengthen Inspection Efforts to Protect the US Food ...
Fast Company

FDA drug-plant inspections still haven’t recovered from the pandemic, AP reports

As COVID-19 swept across the globe in early 2020, the Food and Drug Administration (FDA) pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical ...
MD&M East

Wanted: More Participants for FDA’s Third-Party Inspection

In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number ...
Homeland Security Today

COVID-19 Complicates Already Challenged FDA Foreign Inspection Program, Says GAO

An FDA investigator prepares a test sample for IMS analysis from a shipment of dietary supplements that arrived at the Port of Buffalo in Buffalo, N.Y. (FDA photo) The outbreak of COVID-19 has called ...
Food Safety News

FDA releases more inspection documents from ByHeart infant formula plants

The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...